Healthy Japanese
Conditions
Interventions
Duration: Four weeks The test food
Duration: Four weeks The placebo food
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals who are dissatisfied with their sleep
Exclusion criteria
Exclusion criteria: Individuals who/whose 1.are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2.have a pacemaker or an implantable cardioverter defibrillator 3.are currently undergoing treatment for cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, immune disease, or other chronic diseases 4.are undergoing medical treatment or have a medical history for psychiatric disorder (e.g., depression), sleep apnea syndrome, hypersomnia, narcolepsy, insomnia, or heart valve disease 5.are aware of snore, excessive daytime sleepiness, awakening with a feeling of choking during sleep, panting, insomnia, or remarks from others about interrupted breathing during sleep 6.are smokers 7.have quit smoking within 3 months before agreeing to participate 8.consume foods that improve or inhibit sleepiness before sleep 9.use products that improve or inhibit sleepiness before sleep 10.sleeping habits are irregular due to night shifts and other lifestyle reasons 11.are night workers, shift workers or hard workers 12.sleep in the same room with more than one person, live with preschool children or care recipients, may be disturbed from sleep by others 13.may undergo surgery or tooth extraction during the intervention period 14.are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 15.are taking or using medications (including herbal medicines) and supplements 16.have allergies (medicines and the test food related products), especially milk 17.are pregnant, lactating, or planning to become pregnant during this study 18.have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 19.are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of sleepiness on rising measured by visual analogue scale (VAS) at four weeks after intervention (4w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount of change of sleepiness on rising measured by VAS between before intervention and 4w 2. The measured value and the amount of change from before intervention of subjective fatigue measured by VAS at 4w 3. The measured values and the amount of changes from before intervention of "sleepiness on rising", "Initiation and maintenance of sleep", "frequent dreaming", "refreshing", "sleep length", and each item in the OSA sleep inventory MA version (OSA-MA) at 4w 4. Sleep time, sleep stage (each time of rapid eye movements (REM) sleep, light sleep and deep sleep) and sleep score (sleep quality) | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed